MedPath

Compass Course: Efficacy Study

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Behavioral: Compass Course
Registration Number
NCT03442686
Lead Sponsor
Allina Health System
Brief Summary

The Compass Course is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course intervention.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
41
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Spring 2018 Compass Course GroupCompass CourseTwo groups of up to 15 participants (30 total) will receive the study intervention during Spring 2018. All participants will complete study questionnaires before and after the Spring sessions.
Primary Outcome Measures
NameTimeMethod
Change in psychological well-beingWill be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow up

Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, \& Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

Secondary Outcome Measures
NameTimeMethod
Time of pre-testing sessionDuration of pre-testing session (approximately 2 hours) at week 0 to week 1

Actual length (in minutes) of pre-testing session.

Time of post-testing sessionDuration of session 8 (at week 12), approximately 1 hour

Actual length (in minutes) of testing session.

RecruitmentUp to 1 month after IRB approval

Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study

Time of testing sessionEach week from week 2 through week 8, approximately 2 hours at each session

Actual length (in minutes) of testing session.

Homework completionEach week from week 2 through week 8

Whether or not homework was attempted

Intervention fidelityEach week from week 2 through week 8

Which key intervention elements were provided during a given session

Change in Meaning in lifeAt week 0 and at week 12, and at 3 month follow up

Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).

Purpose Status and ExpectationsAt week 0, at week 12, and at 3 month follow up

A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.

Participant Experience of Compass CourseAt week 12 and at week 14-20

Participant experience of Compass Course as measured by self-report questionnaire and post-intervention focus group.

Engagement in Meaningful ActivitiesAt week 0 and at week 12

Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.

Trial Locations

Locations (3)

Abbott Northwestern Hospital

🇺🇸

Minneapolis, Minnesota, United States

Allina Health Shoreview Clinic

🇺🇸

Shoreview, Minnesota, United States

Courage Kenny Rehabilitation Institute

🇺🇸

Golden Valley, Minnesota, United States

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